Preparation Protocol for the First Pediatric Dental Visit

Behavior, Child Clinical Trial

— PREP  

Official title:

Randomized Clinical Trial to Test a Preparation Protocol for the First Pediatric Dental Visit.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05608720
• Other study ID #: bagattoni1
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: October 1, 2019

Study information

• Verified date: November 2022
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To date, not enough attention has been paid to the role of communication before the first dental visit to encourage the child's cooperation and avoid dysfunctional behaviors. The dentist can provide parents with the information they need to adequately prepare the child for treatment. The present study aims to investigate the effectiveness of an infor-mation booklet to promote pediatric patients' cooperation during the first dental visit

Description:

The aim of the study was to test an Information Booklet preparing the child to the first dental vis-it. Forty-five children and one parent per included child took part in the trial. Children were ran-domized in two groups: the Information Booklet was e-mailed to the parents of the study group. At the end of the visit, the dentist and the parent evaluated the child's behavior through the Frankl Behavior Rating Scale (FBRS) and the utility of the Booklet through a Likert scale. The children evaluated the pleasantness of the visit and the perceived pain through the Wong-Baker FACES® Pain Rating Scale (WBFPRS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

Inclusion Criteria:

• child requiring a first dental visit

Exclusion Criteria:

• previous dental visits, intellectual disability, mother tongue other than Italian, una-vailable e-mail address

Related Conditions & MeSH terms

• Behavior, Child
• Dentist-Patient Relations

Intervention

Behavioral:
• Information Booklet
Information Booklet prior to the dental visit

Locations

Country	Name	City	State
Italy	Servizio di Assistenza Odontoiatrica per disabili in età evolutiva e di odontoiatria infantile	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	child's behavior assessed by dentist with the Frankl Behavior Rating Scale (FBRS)	FBRS: values from 1 (Definitely negative) to 4 (definitely positive)	immediately after the intervention
Secondary	self reported pain assessed by the Wong Baker faces pain rating scale (WBFPRS)	WBFPRS: from 0 (no hurt) to 10 (hurts worst)	immediately after the intervention